Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

Trial Information

Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population

Lung carcinoma is one the most fatal cancer in the world. The enormous fatality rate
reflects the limited chance of cure, with a dismal overall 5-year survival rate of
approximately 14%. The prognosis of lung cancer depends largely on early detection and
immediate treatment prior to metastatic spread. For Stage 1 lung cancer the 5-year survival
rate can be as high as 70% . These data suggest that early detection and surgical treatment
would have a huge beneficial effect on the lung cancer population. We developed a single arm
observational study for the early detection of lung cancer with low dose CT scan in high
risk asymptomatic subjects. A mainly non invasive algorithm for management of undetermined
nodules was designed including low dose CT at three months for baseline nodules with
diameter between 5 and 8 mm, a PET scan for nodules larger that 8 mm (not reduced after
antibiotics and one month follow up CT). Lesions increasing in diameter or in density or
positive nodules at CT/PET were sent to surgical biopsy (videothoracoscopic approach
preferred).

Spirometry was done in all subjects prior to CT scan to evaluate correlation between BPCO
and lung cancer.

Inclusion Criteria:

- Age ≥ 50

- Current daily smokers or former smokers (total dose ≥ 20 pack/year, calculated by
multiplying the number of packs per day by the total number of years smoked)

- Former smoker should have stopped smoking within the 10 years before the inclusion in
the study protocol

Exclusion Criteria:

- Not currently suffering from malignant disease or having had malignant disease within
the last 5 years

- Not having known pulmonary pathology

- Not having performed a chest CT scan during the last 2 years

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

To determine the prevalence of malignant pulmonary disease at the first CT examination

Outcome Description:

CT scan

Outcome Time Frame:

once after enrollment

Safety Issue:

No

Principal Investigator

Massimo Bellomi, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Institute of Oncology

Authority:

Italy: Ministry of Health

Study ID:

IEO S39/100

NCT ID:

NCT01248806

Start Date:

October 2004

Completion Date:

December 2014

Related Keywords:

Subjects at High Risk of Lung Cancer Due to Smoking

Lung nodule

Screening

Spiral low - dose computed tomography

Lung cancer

Lung Neoplasms

Smoking

Name

Location

We are a Cancer Social Network, Resource Directory & Education Hub supporting all those affected by cancer. knowcancer.com is intended to be solely for informational purposes and should not be a substitute for professional medical advice, diagnosis or treatment.